Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topica Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01044381
First received: January 4, 2010
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.


Condition Intervention Phase
Onychomycosis
Drug: Luliconazole Solution, 10%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Open-Label Study Evaluating the Pharmacokinetics, Safety and Tolerability of Luliconazole Solution, 10% in Subjects With Moderate to Severe Distal Subungual Onychomycosis

Resource links provided by NLM:


Further study details as provided by Topica Pharmaceuticals:

Primary Outcome Measures:
  • PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of linear toenail growth. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Luliconazole Solution, 10% Drug: Luliconazole Solution, 10%
28 days of daily application

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years
  • Distal Subungual Onychomycosis(DSO)on both great toenails with >=50%involvement of at least 1 great toenail
  • At least 4 additional toenails with DSO
  • Positive KOH and culture
  • Normal renal and hepatic function

Exclusion Criteria:

  • Subjects with hypersensitivity to imidazole compounds or any other ingredient
  • Subjects unwilling to refrain from use of nail cosmetics until end of study
  • Subjects with symptomatic tinea pedis
  • Subjects with any history of cardiac disease of cardiac rhythm abnormalities
  • Female subjects who are pregnant, nursing, or planning a pregnancy
  • Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks.
  • Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer
  • Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks
  • Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months
  • Subjects with anatomic abnormalities of the toe(s) and or toenails
  • Subject who have donated or lost a large volume of blood (~500 mL or more, during the previous 6 weeks
  • Subjects with a recent history of or currently known to abuse drugs or alcohol
  • Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044381

Locations
United States, Texas
J&S Studies
College Station, Texas, United States, 77840
Sponsors and Collaborators
Topica Pharmaceuticals
Investigators
Principal Investigator: Terry M Jones, M.D. J&S Studies
  More Information

No publications provided

Responsible Party: Topica Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01044381     History of Changes
Other Study ID Numbers: TP-0901-S
Study First Received: January 4, 2010
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Topica Pharmaceuticals:
Toenail
Fungal Infections
DSO

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014